Introduction: Daratumumab, a human IgG monoclonal antibody against CD38 has direct and indirect antimyeloma activity. Daratumumab monotherapy in heavily pretreated patients with multiple myeloma has shown substantial efficacy. We conducted a meta-analysis to demonstrate its efficacy in combination therapy in patients with relapsed or refractory multiple myeloma focusing on clinical outcomes and prognostic factors.

Methods: A comprehensive search was carried out in PubMed, Cochrane and Clinicaltrials.gov using the following MeSH terms: “daratumumab” or “Darzalex” and “multiple myeloma” from 2000 to 2024. Studies comparing daratumumab with combination therapy versus combination therapy alone were taken into consideration. Mantel-Haenzel formula was used to calculate the pooled risk ratio (RR), and Generic Inverse Variance method was used to assess pooled hazard ratio for disease progression in RevMan version 5.4 at 95% confidence interval (CI). P value <0.05 was considered to be significant.

Result: We analyzed 7 phase-III RCTs including 2048 patients. The hazard ratio for progression or death with daratumumab group versus control was significantly lower (HR= 0.44; 95% CI= 0.33 to 0.60; p<0.00001). The RR of overall response rate (ORR) was higher in daratumumab group versus control (RR= 1.25; 95% CI= 1.16 to 1.34; p<0.00001), as were the rates of complete response (CR) (RR= 2.49; 95% CI= 1.91 to 3.24; p<0.00001), very good partial response (VGPR) (RR= 1.64; 95% CI= 1.44 to 1.87; p<0.00001). In terms of prognostic factors, the rate for minimal residual disease (MRD)-negativity rate was also higher for the daratumumab group compared to the control group (RR= 5.32; 95% CI= 3.73 to 7.58; p<0.0001).

Conclusion: Daratumumab affects diverse facets of multiple myeloma and has shown a favorable efficacy in patients with relapsed or relapsed and refractory multiple myeloma. In combination therapy, daratumumab resulted in significantly prolonged disease progression, improved clinical outcomes and prognostic factors through increasing MRD-negativity rates.

Disclosures

No relevant conflicts of interest to declare.

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2024
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